August 29th, 2008 Posted in Random Health | 2 Comments »
In November 2004, when four people became paralyzed after purportedly receiving Botox Cosmetic injections at a medical clinic in Oakland Park, Fla., the Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI) was called to investigate. The four victims were hospitalized with severe botulism poisoning. The paralysis was temporary—a result of being injected with potent, unapproved botulinum toxin. The doctor who injected the toxin had passed it off as Botox Cosmetic, an FDA-approved drug to treat forehead wrinkles.
What began as one OCI investigation of a Florida medical clinic escalated into 210 investigations of health care professionals throughout the United States. As of July 2008, the work of OCI has led to 68 arrests and 29 convictions of individuals who purposely injected an unapproved, cheaper substitute toxin for FDA-approved Botox Cosmetic into nearly 1,000 unknowing patients.
Under federal law, no form of botulinum toxin may be commercially distributed for use on humans unless it has been approved by FDA. At this time, Botox Cosmetic, made by Allergan Inc. of Irvine, Calif., is the only type of botulinum toxin approved by FDA to temporarily soften the frown lines between the eyebrows. Botox Cosmetic is a sterile, purified version of the same toxin that causes botulism, a severe form of foodborne illness. In both cases, the toxin is produced by the bacterium Clostridium botulinum. The injectable form of sterile, purified botulinum toxin, when used in small doses, locally affects the muscles’ ability to contract, smoothing out frown lines to make them nearly invisible.
Source of the Problem
OCI agents traced the fake Botox Cosmetic used in the Florida clinic to a California laboratory that sold botulinum toxin for research purposes. The agents found more of the laboratory’s research product at Toxin Research International Inc. (TRI) in Tucson, Ariz. TRI was selling the unapproved toxin to health care professionals as a cheaper alternative to Botox Cosmetic. In December 2004, OCI agents seized vials of the botulinum toxin from TRI, along with numerous marketing materials targeted to physicians.
The vials were clearly labeled, “For Research Purposes Only, Not For Human Use.” Invoices and product information sheets carried the same warning. Physicians who bought the cheaper, unapproved product from TRI increased their profits on each treatment by charging their patients the same fee as if they were using the FDA-approved Botox Cosmetic.
OCI agents arrested four individuals associated with TRI. Chad Livdahl, TRI’s president, was convicted of fraud and misbranding a drug and sentenced to nine years in prison. His wife and co-owner, Zahra Karim, was sentenced to almost six years in prison. Other co-conspirators got lesser sentences.
OCI Special Agents examined TRI shipping records to track down more than 200 health care professionals who bought the unapproved drug from TRI. “The physicians were located throughout the country, from Manhattan to Las Vegas,” says Philip Walsky, Assistant Special Agent in Charge in FDA’s OCI Headquarters office. “They’d learn about the drug by going to a conference where TRI would give a spiel and demonstration to sell their product.”
Many of the purchasers of the TRI product have been prosecuted. Some are serving time in federal prison and were ordered to pay restitution to their patients.
“Someone who abuses a position of trust for financial gain and subjects patients to unknown safety risks from unapproved medications will be held accountable,” says Kim A. Rice, FDA Special Agent in Charge of OCI’s Metro Washington Field Office. “FDA will aggressively pursue those who willfully circumvent laws that are in place to protect the consuming public.”
OCI continues to investigate these cases, says Walsky.
How Patients Were Scammed
According to OCI agents, most of the health care professionals misrepresented the fake product to patients, leading them to believe they were receiving the real Botox Cosmetic. Some of the tactics they used were
* advertising in brochures, magazines, and on Web sites that they specialized in treating facial wrinkles with Botox Cosmetic
* displaying a certificate indicating they received training by the Botox Cosmetic manufacturer, when they did not
* informing patients they would be receiving Botox Cosmetic
* failing to tell patients they were getting a drug not approved for human use
* asking patients to sign a consent form indicating they would be receiving injections of FDA-approved Botox Cosmetic
For the complete FDA article, click here.
